An Italian company also engaged on the Covid frontProjectWM
The historical period we have been experiencing for about a year and a half has pushed the pharma world to make a significant productive effort, aimed at countering the pandemic emergency. Capsulit S.p.A. is an Italian concrete example.
The company, which has specialized for more than seventy years in the production of closure systems for the pharmaceutical sector, is currently producing caps for anti-Covid vaccines for the EU and US market and has implemented a project that will allow it to further increase the production capacity.
this project allowed us to participate to the AL VIA DGRX/5892 regional call in order to obtain a non-refundable aid financed by Lombardy Region.
Capsulit injectable caps are called Top Cap, have different diameters, shapes and heights, are produced according to ISO standards and can be made entirely of aluminum, plastic, or both. The production takes place in three phases: the cutting of the aluminum part of the cap from aluminum coils, the molding of the plastic disk, through an injection process in multi-cavity molds and the assembly of the two components, using high-speed automatic machines. The hooking systems between the two components can be of different types, always allow an easy opening system and offer a guarantee of inviolability. All versions can be customized with different colors and engraved or printed logos sterilizable in autoclavable.
Furthermore, Top Cap caps can be ready to sterilize and ready to use. The firsts are ready to be sterilized with gamma and beta ray treatment or in autoclave, using processes validated according to ISO 11137. The closures intended for gamma or beta treatment are packed in double polyethylene bags, low density, heat-sealed, according to Capsulit specifications or agreed with the individual customer. The packaging guarantees tightness and sterility for at least three years. The closures intended for autoclave treatment at 131 ° C for 30 ‘ are packaged in heat-sealed Tyvek or Stericlean bags.
RTU ready-to-use caps are gamma-ray treated with a minimum level of 25.0 kGy by specialized partner companies, using processes, validated according to ISO 11137, to guarantee a sterility level of 10-6. Each batch of RTU closures is accompanied by a irradiation certificate issued by the partner company, according to the validated processes and in accordance with the agreed specifications. Upon request, a sterility test by a specialized external laboratory can also be performed on a representative sample of the batch, which issues a sterility certificate. Bioburden checks and dose periodic audits are conducted on cap samples representative of the batches produced, to verify the validity over time of the initial validation, according to the ISO 11137 standard. Capsulit also uses automatic vision systems on the production lines, for prevent cap defects: special robots make it possible to reduce the handling and possible contamination of the caps, through advanced technological systems that respect the logic of Industry 4.0, so that production is constantly monitored and the progress of production orders on the information system is continuous. Everything is done in compliance with good manufacturing standards (GMP) and with particular attention to sustainable development.